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Nebulized Lidocaine and Intranasal Midazolam for NGT Insertion in Children

Primary Purpose

Procedural Anxiety, Procedural Pain

Status
Recruiting
Phase
Phase 3
Locations
Qatar
Study Type
Interventional
Intervention
Nebulized Lidocaine
Intranasal Midazolam
Placebo
Sponsored by
Hamad Medical Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Procedural Anxiety

Eligibility Criteria

6 Months - 5 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

1 Previously healthy children 6 months to 5 years old presenting with AGE and some dehydration who were planned to have a nasogastric tube inserted as part of their ED treatment.

Exclusion Criteria:

  1. Indication for an urgent insertion of a nasogastric tube.
  2. Congenital anomalies of nose, nasopharynx, oropharynx, or oral cavity.
  3. .Patients allergic to midazolam or lidocaine.
  4. .Congenital Heart disease or arrhythmia.
  5. .Known hepatic or renal impairment
  6. .Developmentally abnormal children
  7. .Patients with seizure disorder
  8. .Pre-existing abnormal neurological conditions
  9. .Child is taking medications known to interact with lidocaine and/or midazolam (antiarrhythmic drugs, suxamethonium, phenytoin, antidepressants, propranolol, citicoline).
  10. .Known case of severe gastroesophageal reflux disease or aspiration pneumonia.

Sites / Locations

  • Pediatric Emergency Center, Hamad Medical CorporationRecruiting
  • Sidra Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Arm 1

Arm 2

Arm 3

Arm Description

Nebulized 2% lidocaine hydrochloride 4 mg/kg to be delivered via nebulization (up to a maximum of 15 ml) and given over ½ hr. Intranasal midazolam 0.5 mg/kg delivered via intranasal atomization (up to a maximum of 10 mg).

Intranasal midazolam 0.5 mg/kg to be delivered via intranasal atomization (up to a maximum of 10 mg). Nebulized placebo (Normal saline) in a volume comparable to 2% lidocaine at 4 mg/kg (up to a maximum of 15 ml) and given over ½ hr.

Intranasal placebo (normal saline) in a volume comparable to midazolam 0.5 ml/kg to be delivered via intranasal atomization Nebulized placebo (Normal saline) in a volume comparable to 2% lidocaine at 4 mg/kg (up to a maximum of 15 ml) and given over ½ hr.

Outcomes

Primary Outcome Measures

Pain severity rating scale (FLACC) during insertion of NGT.
score from 0 to 10. Higher scores mean worse outcome

Secondary Outcome Measures

Observer/caregiver pain severity rating:
Score from 1 to 100. Higher scores mean worse outcome
The ease of procedure: difficulty of insertion on an ordinal scale from 1 to 5, where 5 is the most difficult insertion.
Score from 1 to 5. Higher scores mean worse outcome
The number of attempts required to successfully insert the NGT
The number of attempts of successful NGT insertion
Procedural complications/adverse events.
Records complications and adverse effects
FLAC score at 30 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes and 180 minutes post insertion.
Scores from 0 to 10. Higher scores mean worse outcome
Length of stay in ED
Length of stay in minutes
Duration of NGT feed.
The observer records data on chart
Tolerated volume of NGT feed.
Amount of fluid (ml)

Full Information

First Posted
September 10, 2020
Last Updated
March 1, 2023
Sponsor
Hamad Medical Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT04571879
Brief Title
Nebulized Lidocaine and Intranasal Midazolam for NGT Insertion in Children
Official Title
Nebulized Lidocaine and Intranasal Midazolam for Reducing Pain/Anxiety of Nasogastric Tube Insertion in Children: A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 25, 2021 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
February 28, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hamad Medical Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Nasogastric tube (NGT) is a commonly performed procedure in the Emergency Department. Although it is not a major procedure, it is usually associated with a bad experience and cause discomfort and pain in kids. This randomized controlled double-blinded double-dummy trial aims to investigate the efficacy of local topical anesthetic and/or anxiolysis for pain/anxiety related to NGT insertion. Eligible patients are children with gastroenteritis aged 6 months to 5 years requiring NGT rehydration. The intervention are 3 arms of nebulized lidocaine with midazolam compared to nebulized midazolam alone or placebo. The primary outcome is procedure-related pain assessment using the Face, Legs, Activity, Cry, and Consolability (FLACC) scale during final NGT insertion attempt.
Detailed Description
Nasogastric tube (NGT) insertion is commonly performed in the emergency department (ED) which can cause some pain/anxiety [Shih S and Rosen P, 2018]. The pain/discomfort related to NGT insertion comes from anxiety, gagging and sensitivity of nasopharynx and oropharynx [Tapiawala SN et al, 2008]. Success rate depends on cooperation, which limits order for nasogastric tube insertion in most patients especially in non-pediatric hospitals. The pain and anxiety associated with such procedures in kids is a source of noxious stimuli to the nervous system. Not only does pain have a negative impact on neurological development, but children whose pain has not been adequately treated in infancy or early childhood reported lower pain thresholds as adolescents and adults [Ruda M.A.et al, 2000]. If not addressed, this pain can lead to distress for children, their parents and those performing the procedures, preprocedural anxiety in the future and can result in negative long-term emotional outcomes [Blount R.L et al,2006; Brewer S.G. et al, 2006]. Nebulized 2% lidocaine at doses of 4 and 8 mg/kg has shown to be safe in infants and children, with all blood levels obtained were well below the toxic range [Gjonaj S et al, 1997]. Nebulized lidocaine in doses up to 8 mg/kg appears to be safe and gave statistically significant reduction in pain score when used before flexible bronchoscopy [Gjonaj S et al, 1997]. Nebulized/intranasal lidocaine did not seem to be of benefit when used alone in the two previous trials for NGT insertion in children [Babl FE et al,2009; Craig SS et al, 2019]. On the other hand it greatly reduced discomfort associated with NG tube in adult population [Cullen L et al, 2004]. This might be explained by the anxiety and lack of cooperation, especially in young kids, which might limit the validity of pain score during the whole procedure. Midazolam has a controlled sedation with a quicker recovery time. The safety and tolerability profile of midazolam in pediatric patients is comparable/superior to that observed in adults [Pacifici GM, 2014]. Midazolam is a GABA receptor agonist providing anxiolysis for procedures in pediatric population. Midazolam has been shown to be safe and effective for use in children [Wilton NC et al,1988; Theroux MC et al, 1993]. Intranasal midazolam has shown improvements with anxiety and crying, as well as need for restraint [Theroux MC et al, 1993]. Midazolam anxiolysis has been tried in pediatrics and ordered as nebulization, found to have a plasma concentration bioavailability which is comparable to the intranasal midazolam by the ratio (nebulized:nasal) of 1:2.9. [McCormick AS et al, 2008]. Clinically effective serum concentrations of intranasal midazolam can be reached within less than 10 min after nasal application [Knoester PD et al, 2002]. Lidocaine / Midazolam has been commonly used in different procedures in pediatric emergency department; such as urethral catheterization, intravenous cannulation, lumbar puncture with a great safety margin.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Procedural Anxiety, Procedural Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Experimental
Arm Description
Nebulized 2% lidocaine hydrochloride 4 mg/kg to be delivered via nebulization (up to a maximum of 15 ml) and given over ½ hr. Intranasal midazolam 0.5 mg/kg delivered via intranasal atomization (up to a maximum of 10 mg).
Arm Title
Arm 2
Arm Type
Experimental
Arm Description
Intranasal midazolam 0.5 mg/kg to be delivered via intranasal atomization (up to a maximum of 10 mg). Nebulized placebo (Normal saline) in a volume comparable to 2% lidocaine at 4 mg/kg (up to a maximum of 15 ml) and given over ½ hr.
Arm Title
Arm 3
Arm Type
Placebo Comparator
Arm Description
Intranasal placebo (normal saline) in a volume comparable to midazolam 0.5 ml/kg to be delivered via intranasal atomization Nebulized placebo (Normal saline) in a volume comparable to 2% lidocaine at 4 mg/kg (up to a maximum of 15 ml) and given over ½ hr.
Intervention Type
Drug
Intervention Name(s)
Nebulized Lidocaine
Other Intervention Name(s)
Nebulized Xylocaine
Intervention Description
Nebulized Lidocaine for Reducing Pain of Nasogastric Tube Insertion in Children
Intervention Type
Drug
Intervention Name(s)
Intranasal Midazolam
Other Intervention Name(s)
IN Midazolam
Intervention Description
Intranasal Midazolam for reducing anxiety of Nasogastric Tube insertion
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Nebulized normal saline and intranasal normal sline
Primary Outcome Measure Information:
Title
Pain severity rating scale (FLACC) during insertion of NGT.
Description
score from 0 to 10. Higher scores mean worse outcome
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Observer/caregiver pain severity rating:
Description
Score from 1 to 100. Higher scores mean worse outcome
Time Frame
1 year
Title
The ease of procedure: difficulty of insertion on an ordinal scale from 1 to 5, where 5 is the most difficult insertion.
Description
Score from 1 to 5. Higher scores mean worse outcome
Time Frame
1 year
Title
The number of attempts required to successfully insert the NGT
Description
The number of attempts of successful NGT insertion
Time Frame
1 year
Title
Procedural complications/adverse events.
Description
Records complications and adverse effects
Time Frame
1 year
Title
FLAC score at 30 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes and 180 minutes post insertion.
Description
Scores from 0 to 10. Higher scores mean worse outcome
Time Frame
up to 180 minutes
Title
Length of stay in ED
Description
Length of stay in minutes
Time Frame
up to 180 minutes
Title
Duration of NGT feed.
Description
The observer records data on chart
Time Frame
up to 180 minutes
Title
Tolerated volume of NGT feed.
Description
Amount of fluid (ml)
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 1 Previously healthy children 6 months to 5 years old presenting with AGE and some dehydration who were planned to have a nasogastric tube inserted as part of their ED treatment. Exclusion Criteria: Indication for an urgent insertion of a nasogastric tube. Congenital anomalies of nose, nasopharynx, oropharynx, or oral cavity. .Patients allergic to midazolam or lidocaine. .Congenital Heart disease or arrhythmia. .Known hepatic or renal impairment .Developmentally abnormal children .Patients with seizure disorder .Pre-existing abnormal neurological conditions .Child is taking medications known to interact with lidocaine and/or midazolam (antiarrhythmic drugs, suxamethonium, phenytoin, antidepressants, propranolol, citicoline). .Known case of severe gastroesophageal reflux disease or aspiration pneumonia.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fatihi HS Toaimah, PhD
Phone
+97455628632
Email
ftoaimah@hamad.qa
First Name & Middle Initial & Last Name or Official Title & Degree
Khalid Alansari
Email
kalansari@sidra.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fatihi Toaimah, MD, PhD
Organizational Affiliation
Hamad Medical Corporation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pediatric Emergency Center, Hamad Medical Corporation
City
Doha
ZIP/Postal Code
3050
Country
Qatar
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fatihi Toaimah
Facility Name
Sidra Medicine
City
Doha
ZIP/Postal Code
3050
Country
Qatar
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Khalid Alansari, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
30555754
Citation
Shih S, Rosen P. Pain Management for Nasogastric Intubation in Pediatrics. Cureus. 2018 Oct 9;10(10):e3429. doi: 10.7759/cureus.3429.
Results Reference
result
PubMed Identifier
18299545
Citation
Tapaiwala SN, Al Riyami D, Cole E. A painful and knotted nasogastric tube. CMAJ. 2008 Feb 26;178(5):568. doi: 10.1503/cmaj.070750. No abstract available.
Results Reference
result
PubMed Identifier
10915627
Citation
Ruda MA, Ling QD, Hohmann AG, Peng YB, Tachibana T. Altered nociceptive neuronal circuits after neonatal peripheral inflammation. Science. 2000 Jul 28;289(5479):628-31. doi: 10.1126/science.289.5479.628.
Results Reference
result
PubMed Identifier
16330518
Citation
Blount RL, Piira T, Cohen LL, Cheng PS. Pediatric procedural pain. Behav Modif. 2006 Jan;30(1):24-49. doi: 10.1177/0145445505282438.
Results Reference
result
PubMed Identifier
16428010
Citation
Brewer S, Gleditsch SL, Syblik D, Tietjens ME, Vacik HW. Pediatric anxiety: child life intervention in day surgery. J Pediatr Nurs. 2006 Feb;21(1):13-22. doi: 10.1016/j.pedn.2005.06.004.
Results Reference
result
PubMed Identifier
9404766
Citation
Gjonaj ST, Lowenthal DB, Dozor AJ. Nebulized lidocaine administered to infants and children undergoing flexible bronchoscopy. Chest. 1997 Dec;112(6):1665-9. doi: 10.1378/chest.112.6.1665.
Results Reference
result
PubMed Identifier
19482767
Citation
Babl FE, Goldfinch C, Mandrawa C, Crellin D, O'Sullivan R, Donath S. Does nebulized lidocaine reduce the pain and distress of nasogastric tube insertion in young children? A randomized, double-blind, placebo-controlled trial. Pediatrics. 2009 Jun;123(6):1548-55. doi: 10.1542/peds.2008-1897.
Results Reference
result
PubMed Identifier
31000379
Citation
Craig SS, Seith RW, Cheek JA, Wilson K, Egerton-Warburton D, Paul E, West A. Lidocaine and phenylephrine versus saline placebo nasal spray for the pain and distress of nasogastric tube insertion in young children and infants: a randomised, double-blind, controlled trial. Lancet Child Adolesc Health. 2019 Jun;3(6):391-397. doi: 10.1016/S2352-4642(19)30058-6. Epub 2019 Apr 15.
Results Reference
result
PubMed Identifier
15278085
Citation
Cullen L, Taylor D, Taylor S, Chu K. Nebulized lidocaine decreases the discomfort of nasogastric tube insertion: a randomized, double-blind trial. Ann Emerg Med. 2004 Aug;44(2):131-7. doi: 10.1016/j.annemergmed.2004.03.033.
Results Reference
result
PubMed Identifier
24696691
Citation
Pacifici GM. Clinical pharmacology of midazolam in neonates and children: effect of disease-a review. Int J Pediatr. 2014;2014:309342. doi: 10.1155/2014/309342. Epub 2014 Feb 18.
Results Reference
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PubMed Identifier
3195771
Citation
Wilton NC, Leigh J, Rosen DR, Pandit UA. Preanesthetic sedation of preschool children using intranasal midazolam. Anesthesiology. 1988 Dec;69(6):972-5. doi: 10.1097/00000542-198812000-00032. No abstract available.
Results Reference
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PubMed Identifier
8441570
Citation
Theroux MC, West DW, Corddry DH, Hyde PM, Bachrach SJ, Cronan KM, Kettrick RG. Efficacy of intranasal midazolam in facilitating suturing of lacerations in preschool children in the emergency department. Pediatrics. 1993 Mar;91(3):624-7.
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PubMed Identifier
18385262
Citation
McCormick AS, Thomas VL, Berry D, Thomas PW. Plasma concentrations and sedation scores after nebulized and intranasal midazolam in healthy volunteers. Br J Anaesth. 2008 May;100(5):631-6. doi: 10.1093/bja/aen072. Epub 2008 Apr 2.
Results Reference
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PubMed Identifier
11994056
Citation
Knoester PD, Jonker DM, Van Der Hoeven RT, Vermeij TA, Edelbroek PM, Brekelmans GJ, de Haan GJ. Pharmacokinetics and pharmacodynamics of midazolam administered as a concentrated intranasal spray. A study in healthy volunteers. Br J Clin Pharmacol. 2002 May;53(5):501-7. doi: 10.1046/j.1365-2125.2002.01588.x.
Results Reference
result

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Nebulized Lidocaine and Intranasal Midazolam for NGT Insertion in Children

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